drugset / Trial / NCT06041919
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
RandomizedParallel-groupSingle-blindTreatment
Summary
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Timeline
- Start
- 2023-09-27
- Primary completion
- 2024-07-24
- Completion
- 2025-03-06
Outcome
Outcome not reported
Stopped: “Decision was made by the sponsor not to progress to Stage 2”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ethambutol | Small molecule | 275 mg | Oral |
| Subject | Isoniazid | Small molecule | 75 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 400 mg | Oral |
| Subject | RESP301 | Other / unclassified | 6 ml | Inhaled |
| Subject | Rifampicin | Small molecule | 150 mg | Oral |